Encapsulating the COVID-19 vaccine race: the developer

Founded by Dr Jeff Drew in 2005, Stabilitech - a UK based biotechnology company developing next generation vaccines and biopharmaceuticals - has the potential to disrupt vaccine delivery as Amazon and Alibaba have disrupted the high street. Having developed the first oral Zika vaccine, the company now believes that the near future is self-administered vaccine capsules that are thermally stable, inexpensive to make, developed in weeks, and distributed by mail.

Q: How did Stabilitech get into the COVID-19 vaccine race?

A: We moved from giving thermal stability to other company’s vaccines to developing our own vaccines three years ago. Before the COVID-19 pandemic hit and steadily took the lives of loved ones all around the globe, we had successfully created an oral vaccine for Zika virus. Our initial trials and reports showed us that our thermally stable patented technology, OraPro, can deliver a vaccine via an oral capsule to the GI tract without loss of efficacy. We realised the urgency for a vaccine for COVID-19 and therefore focused our efforts to finding a solution for SARS-CoV-2.

The OraPro-COVID-19 capsule is set for our first human trials starting in August 2020.

Q: How does your vaccine delivery system work?
A: OraPro-COVID-19 uses a non-replicating adenovirus-5 as a viral vector with the SARS-CoV-2 spike-protein as a cargo to deliver the vaccine to epithelial cells in the gastrointestinal tract and thus should be able to generate both a mucosal and systemic immune response.

Viral vectors are thermally unstable and need to be maintained at -80°C. To get a vector through the stomach, where they sit at 37°C for several hours before transporting to the small intestine, is normally impossible without the vector being rendered inefficacious.

Stabilitech’s OraPro™ technology gives the vector thermal stability at up to 50°C for weeks and two years at room temperature. This enables it to pass through the stomach without loss of efficacy and allows oral administration.

This breakthrough in vaccine delivery is translated into capsule form. This is less expensive to produce than traditional counterparts and allows for repeat administration of the same viral vector – unlike injections where the same vector can only be used once or twice due to individuals becoming immune to the vector itself.

Q: What advantages does this delivery system offer?

A: The OraPro-COVID-19 capsules contain a freeze-dried COVID-19 vaccine and are thermally stable, which means they do not need refrigeration, unlike most other vaccines. This reduces the cost as there is no need for an expensive cold- or cryo-chain for storage and delivery.

They can be simply mailed and self-administered. Even the most vulnerable and shielded can benefit without a high-risk visit to a healthcare professional. No injections, no needles, no nurse or doctor’s visit, therefore no need for PPE that maybe in short supply.

Q: What did you need funding for and how did you go about raising it?

A: Vaccine development is very expensive, and we required funding to help us get to the next phase of our research and development which is manufacturing to cGMP level and the initial clinical trial. Following this phase, we are hopeful that the government will engage and take it to the next level.

Clinical trials are due to start in August 2020. With the government’s help, we believe we can get MHRA marketing approval within six months. If we must do it on our own, it will take longer.

Q: As a small business with a big offering, did you find it easy to have your technology acknowledged?

A: Getting recognition is very difficult. There are many competing technologies – we almost certainly just happen to have the best approach in the world for COVID-19 (that targets both mucosal and systemic immunity). It has helped that we have been recognised by the WHO and are on their list of approved vaccine developers. The proof will be whether we get a strong immune response in our clinical trials.

Q: What is it like weighing up against established organisations such as Oxford?
A: Oxford has a great reputation and a very good product. It is based on highly similar technology so their safety results should be representative of what we can expect. The main difference is that they have to inject whereas we administer orally. That may be the decisive point – COVID-19 is a mucosal virus and we have the only vaccine that directly targets the virus where it resides in the mucosa.

There are a number of other differences that are meaningful in the pandemic perspective – can enough doses be manufactured? There is a global shortage of cryo-vials and this is a boring but important limit on any vaccine that is not thermally stable. How much vaccine needs to be produced depends on the efficacy which in turn should mean we need to administer less. Even shipment of a -80°C vaccine will be problematical – there simply aren’t enough -80°C freezers available, even in the UK, let alone the rest of the world. Contrast this against thermally stable capsules – they are made in the billions and can be shipped in the mail – it is a world of difference.

This is a linked interview. Read Encapsulating the COVID-19 vaccine race: the investor here.

Wayne Channon, Chairman, Stabilitech Biopharma, is a successful entrepreneur with experience of managing high growth companies from start-up to exit
stabilitech.com